Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol

ABSTRACT

Nirsevimab has been recently licensed for universal RSV prophylaxis in infants. NIRSE-GAL is a three-year population-based study initiated in Galicia in September 2023. It aims to evaluate nirsevimab effectiveness against RSV-related hospitalizations lower respiratory tract infections (LRTI), severe RSV, all-cause LRTI, and all-cause hospitalization. NIRSE-GAL also aims to estimate nirsevimab impact on primary healthcare use in the short and mid-term, children’s wheezing and asthma, and medical prescriptions for RSV. The immunization campaigns will be scheduled based on the expected start week for the RSV season and will last the whole season. Immunization will be offered to: i) infants born during the campaign (seasonal), ii) infants < 6 months at the start of the campaign (catch-up), and iii) infants with high-risk factors, aged 6–24 months at the start of the campaign (high-risk). The follow-up period will start: i) the immunization date for all immunized infants, ii) the start of the campaign, for the non-immunized catch-up or high-risk groups, or iii) the birthdate for the non-immunized seasonal group. Infants will be followed up until outcome occurrence, death, or end of study. Nirsevimab effectiveness will be estimated using Poisson and Cox regression models. Sensitivity and stratified analyses will be undertaken. The number of averted cases and the number needed to immunize will be estimated. Immunization failure and nirsevimab safety will be monitored. NIRSE-GAL was approved by the ethics committee of Galicia (CEIC 2023–377) and registered in ClinicalTrials.gov (ID: NCT06180993). Findings will be mainly shared via peer-reviewed publications and scientific conferences.

KEYWORDS:

• Effectiveness
• immunization
• longitudinal population-based study
• lower respiratory tract infection
• nirsevimab
• respiratory syncytial virus

Acknowledgments

The NIRSE-GAL study (CEIC 2023–377, ClinicalTrials.gov number NCT06180993) is funded by Sanofi/AstraZeneca through a research grant to the Healthcare Research Institute of Santiago de Compostela. This work was also supported by a Framework Partnership Agreement between the Consellería de Sanidad de la Xunta de Galicia and GENVIP-IDIS-2021–2024 (SERGAS-IDIS March 2021; Spain). In addition, it received support from i) ISCIII: TRINEO: PI22/00162; DIAVIR: DTS19/00049; Resvi-Omics: PI19/01039 (to A.S.), ReSVinext: PI16/01569, Enterogen: PI19/01090, OMI-COVI-VAC: PI22/00406 (to F.M.-T.), cofinanced FEDER, ii) GAIN: IN607B 2020/08 and IN607A 2023/02 (to A.S.), GEN-COVID (IN845D 2020/23 (to F.M.-T.), IIN607A2021/05 (to F.M.-T.); iii) ACIS: BI-BACVIR (PRIS-3, to A.S.), CovidPhy (SA 304 C, to A.S.); and iv) Consorcio Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CB21/06/00103; to A.S. and F.M.-T.). This study is also supported by grants from the Galician Supercomputing Center (CESGA), the Spanish Ministry of Science and Innovation, the Galician Government, and the European Regional Development Fund (ERDF), the European Seventh Framework Programme for Research and Technological Development (FP7) under EUCLIDS project (Grant Agreement number 279185).

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2024.2348135.

Authors contribution statement

Narmeen Mallah: literature search, investigation, methodology, writing – original draft, and writing – review & editing. Sonia Ares-Gomez: investigation, methodology, administration: and writing – review & editing. Jacobo Pardo-Seco, Alberto Malvar-Pintos, and Maria-Isolina Santiago-Perez: methodology. Olaia Pérez-Martinez, María-Teresa Otero-Barros, Nuria Suarez-Gaiche, Rosa-María Alvarez-Gil, Olga-María Ces-Ozores, Victoria Nartallo-Penas, Susana Mirás-Carballal, Marta Piñeiro-Sotelo, Juan-Manuel González-Pérez, Carmen Rodriguez-Tenreiro-Sánchez, Irene Rivero-Calle, and Antonio Salas: resources and project administration. Rolf Kramer, Jing Jin, Leticia Platero-Alonso: methodology. Carmen Duran-Parrondo: supervision, resources, project administration. Federico Martinón-Torres: conceptualization, funding acquisition, investigation, methodology, project administration, resources, supervision, validation, visualization. All authors: writing – review & editing. Narmeen Mallah, Sonia Ares-Gomez and Federico Martinón-Torres: equal contribution.

Disclosure statement

Federico Martinón-Torres has acted as principal investigator in randomized controlled trials of Ablynx, Abbot, Seqirus, Sanofi Pasteur MSD, Sanofi Pasteur, Cubist, Wyeth, Merck, Pfizer, Roche, Regeneron, Jansen, Medimmune, Novavax, Novartis and GSK, with honoraria paid to his institution. Federico Martinon-Torres reports a relationship with GSK Vaccines SRL that includes: consulting or advisory. Federico Martinon-Torres reports a relationship with Pfizer Inc that includes: consulting or advisory. Federico Martinon-Torres reports a relationship with Sanofi Pasteur Inc that includes: consulting or advisory. Federico Martinon-Torres reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory. Federico Martinon-Torres reports a relationship with MSD that includes: consulting or advisory. Federico Martinon-Torres reports a relationship with Seqirus Pty Ltd that includes: consulting or advisory. IRC has received speaking fees from MSD, GSK, Sanofi, Moderna and Pfizer. IRC has participated in advisory boards organized by MSD, GSK, Sanofi and Pfizer. IRC has been involved in clinical trials funded by Ablynx, Abbot, Seqirus, Sanofi Pasteur MSD, Sanofi Pasteur, Cubist, Wyeth, Merck, Pfizer, Roche, Regeneron, Jansen, Medimmune, Novavax, Novartis and GSK, although the funds were paid to her institution. Rolf Kramer, Jing Jin and Leticia Platero-Alonso are Sanofi employees and may hold shares and/or stock options in the company. The remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Additional information

Funding

The work was supported by the Axencia Galega de Innovación, Instituto de Salud Carlos III, Centro de Investigación Biomética en Red e Enremades Respiratorias, and Sanof-Pasteur.